The results of the LUPER clinical trial investigating the efficacy of the combination of lurbinectedin and pembrolizumab in patients with small-cell lung cancer were positive and have prompted further research.
The results of the project, which investigated the correlation between Trop-2 protein levels and treatment response in early-stage HER2-positive breast cancer, concluded that Trop-2 expression levels may be a biomarker for treatment resistance and could become a target for future therapeutic combinations.
The HER2DX genomic test could be a useful tool to guide patients and their doctors in personalizing treatment for HER2-positive early breast cancer.
MEDSIR, founded by three scientists with an extensive background in clinical innovation, has launched more than 50 clinical trials to improve cancer treatments since 2012.
Grupo Oncoclínicas, MEDSIR's strategic partner in Brazil and Latin America, also presented its research projects at ESMO.
Madrid, 21 October 2023 - MEDSIR, a company specializing in the strategic design of independent clinical research, today presented the results of three new studies at the European Society for Medical Oncology (ESMO 2023), one of the most prestigious oncology platforms for clinicians, researchers and healthcare industry representatives in Europe and with global influence: LUPER, focused on patients with small-cell lung cancer; and two translational studies extending the results of the PHERGain study, focused on HER2-positive breast cancer.
With the results of these three studies, MEDSIR reinforces its commitment to leading independent clinical research to improve the quality of life of cancer patients by providing a comprehensive operational and funding structure for investigators with innovative ideas to develop clinical trials anywhere in the world. The pan-tumor research company reached a major milestone with the presentation of the landmark results of the PHERGain study at ASCO 2023, the American Society of Clinical Oncology, in June. These results showed that approximately one third of patients with early-stage HER2-positive breast cancer could be treated without chemotherapy and remain free of breast cancer for up to three years after surgery. PHERGain is a groundbreaking trial that uses a personalized treatment strategy for each patient. On the other hand, Grupo Oncoclínicas, MEDSIR’s strategic partner in Brazil and Latin America, also attended ESMO and presented its research projects.
LUPER: Efficacy and safety through a combination of lurbinectedin and pembrolizumab in patients with small cell lung cancer
The LUPER trial, which was presented during an oral session at the congress, is being led by Dr. Antonio Calles, a medical oncologist at the Gregorio Marañón Hospital in Madrid.
The LUPER trial is evaluating the efficacy of the combination of lurbinectedin (a drug that promotes tumor cell death and regulates the ecosystem surrounding a tumor in the body) and pembrolizumab (an immunotherapy drug) in patients with small-cell lung cancer (SCLC) who have relapsed after initial platinum-based chemotherapy. A total of 28 patients with SCLC who had not previously received immunotherapy were enrolled in the LUPER trial.
The analysis of results from the ongoing LUPER study shows that the combination of lurbinectedin and pembrolizumab is effective in treating patients with SCLC who have relapsed after platinum-based chemotherapy without prior immunotherapy. The main results of the study were presented at ESMO and show that more than 46% of patients experienced a reduction in tumor size (objective response rate), in some cases with strong and durable responses lasting more than 12 months.
Lurbinectedin is approved by the US Food and Drug Administration (FDA) for the treatment of metastatic small-cell lung cancer patients with progressive disease on or after platinum-based chemotherapy. The results of the LUPER study presented at this edition of ESMO encourage further research into this drug in combination with immunotherapy.
According to the WHO, lung cancer is the second most common cancer in the world after breast cancer. In Spain, it is the third most common cancer after breast and colorectal cancer, with around 20,000 new cases diagnosed each year. It occurs mainly in men (80%), although the incidence in women (20%) has increased in recent years.
Historically, lung cancer has had one of the highest mortality rates compared to other cancers, but research and the discovery of a group of genetic alterations have allowed for more effective treatment of patients and has led to significant progress in curing and surviving the disease.
Smoking is the major risk factor for lung cancer. Ninety per cent of new cases are diagnosed in people who smoke. If tobacco use were to be eliminated, the number of new cases could be reduced by 30%.
The two main types of lung cancer are: non-small cell lung cancer (85% of cases) and small cell lung cancer (15% of cases), the latter being the focus of the LUPER study. This type of cancer is almost always associated with smoking and often responds well to initial treatment. However, it is associated with aggressive growth, which means that most patients are not cured, will relapse, and can even develop resistance to the original therapy. Once the tumor has progressed, the prognosis is very poor, and the therapeutic options are limited. In fact, the survival rate for these patients has not improved in the last 20 years, despite advances in treatment.
It is therefore a cancer with a clear unmet need for innovative treatment options that may be viable for patients with small-cell lung cancer whose cancer has progressed on first-line chemotherapy.
Currently, patients with early-stage HER2-positive breast cancer, that is, when the tumor has not spread beyond the breast, are treated with a combination of chemotherapy and therapies that specifically target the HER2 protein. However, patients' responses vary, and it is difficult to assess whether they are receiving the best treatment option. There is an urgent need to develop tools that can help predict the effectiveness of these targeted therapies and the risk of relapse. With this in mind, MEDSIR also presented the results of two translational studies related to the PHERGain trial, both investigating molecular strategies to guide personalized treatment for patients with early HER2-positive breast cancer.
PHERGain TRANSLATIONAL STUDIES in breast cancer
Trop-2, a biomarker for treatment resistance in HER2-positive breast cancer patients?
In the first of the translational studies presented by MEDSIR at ESMO, we analyzed the expression levels of the Trop-2 protein in tumor samples from patients with HER2-positive early breast cancer. The aim is to determine whether there is a link between the levels of this protein prior to treatment and pathological complete response (the absence of residual cancer cells) to the standard treatment for this type of cancer. The study is being led by Dr María Gion.
The Trop-2 protein is present at low levels in healthy cells, but elevated levels of this protein have been found in many cancers and is associated with increased tumor aggressiveness, metastasis and poor outcome. However, the role of Trop-2 in HER2-positive breast cancer patients and whether Trop-2 is able to predict disease progression or response to treatment (two important parameters for clinicians) remains largely unexplored.
Researchers found that patients who had high levels of the Trop-2 protein prior to treatment had lower pathological complete response rates, meaning they were less likely to respond to treatment, while patients who did not have high levels of Trop-2 protein were significantly more likely to achieve a response. Therefore, Trop-2 could potentially be used in future research to identify patients who are most likely to benefit from treatment. This also opens up the possibility of it becoming a target for future therapeutic combinations.
HER2DX®: a genomic test for predicting patient survival
Another study presented, with the aim of identifying strategies to select the most appropriate treatment for patients with early HER2-positive breast cancer, compared the association between the HER2DX® test prediction of pathological complete response with actual pathological complete response observed in the PHERGain clinical trial; and the HER2DX® risk (prognostic) score with actual clinical data on invasive disease-free survival 3 years after surgery. This study was performed on samples and clinical data from 292 patients who participated in the PHERGain clinical trial (82% of the total number of participants).
This project was led by Dr Antonio Llombart-Cussac, in collaboration with Dr Javier Cortés (both co-founders of MEDSIR), with REVEAL GENOMICS, S.L. as the main scientific partner, led by Dr Aleix Prat.
HER2DX ® is an in vitro diagnostic test developed by REVEAL GENOMICS, S.L. HER2DX ® is the first genomic tool for patients with early-stage HER2-positive breast cancer. The test measures the expression of 27 cancer-related genes and combines this information with clinical characteristics such as tumor size and lymph node involvement. This personalized data is then processed by an algorithm that calculates two independent scores: one indicating a patient's likelihood of relapse (prognosis) after treatment with trastuzumab-based chemotherapy (risk score) and another indicating the likelihood of response to anti-HER2 treatment (pathological complete response probability score).
According to the results of the study presented at ESMO, the HER2DX® test was not only able to predict pathologic complete response following neoadjuvant pertuzumab and trastuzumab (with or without chemotherapy), but also identified patients with an increased likelihood of relapse. These results help to further validate the HER2DX® genomic test and could help personalize pertuzumab- and trastuzumab-based therapy for early-stage HER2-positive breast cancer.
The HER2DX® genomic test may prove to be a valuable tool to guide healthcare professionals and patients in personalizing treatment for HER2-positive early breast cancer.
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